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Completed

NCT Number: NCT00116493

Severe Anemia Treatment Trials, Pakistan

The purpose of this study is to test the efficacy of two enhanced regimens (deworming and multivitamins) in the treatment of severe anemia in pregnant women and children 6-24 months of age in Karachi, Pakistan.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

6 month–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aga Khan University

Karachi, Sindh, Pakistan

About this study

Anemia continues to be a public health problem of global proportions. Severe anemia (hemoglobin, Hb< 70 g/L) is of special concern as it poses a significant health and mortality risk. Pregnant women and young children (6-24 months of age) are the two groups at highest risk. Severe anemia in pregnant women is associated with an elevated risk of maternal and perinatal mortality as well as case fatality. Pakistan, the country in which this study is ongoing, may harbor the highest prevalence of severe anemia in South Asia, with as high as 15% being reported among pregnant women. Comparable rates (11-12%) are also seen among 6-24 month old children. Iron deficiency is one of the major causes of anemia in young children and pregnant women in South Asia. In addition to iron, deficiency of vitamins such as folic acid, vitamin A, vitamin C, riboflavin and vitamin E can also inhibit erythropoiesis. Apart from these nutritional causes, two other infectious causes of severe anemia are malaria and geohelminths. The current international recommendation for treatment of anemia includes iron and folic acid but not other vitamins.

Comparisons: Severely anemic pregnant women and children 6-24 months are randomized to receive enhanced treatment of deworming and multivitamins over and above the standard of care of iron-folic acid using a 2x2 factorial design.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women with severe anemia (Hb<70g/L)
  • Children 6-24 months with severe anemia (Hb<70 g/L)

Exclusion criteria

  • Gestational age >=36 weeks
  • Edema
  • Breathlessness

Treatment and study plan

Iron-folic acid and mebendazole

Dietary Supplement

100 mg iron for pregnant women, 25 mg iron for children

1 mg of folic acid for pregnant women, 100 ug folic acid for children 500 mg of mebendazole for both pregnant women and children

Mebendazole

Drug

100 mg twice a day for 3 days; Iron-folic acid also given

Multivitamins

Dietary Supplement

Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2

Mebendazole + Multivitamin

Drug

Multivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given

Primary outcomes

  1. Severe Anemia

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Aga Khan University

Registry information

Official study title

Evaluation of Anthelminthics and Multivitamins for Treatment of Severe Anemia in Pregnant Women and Children 6-24 Months of Age in Pakistan

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jun 30, 2005
Registry last updated
Apr 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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